Prostate Cancer

A recap of the FDA submissions and regulatory decisions in urology from June 2025.

A comprehensive guide to the key regulatory decisions and conferences slated for Q3 of 2025.

The unfortunate news of President Biden’s diagnosis has put a spotlight on prostate cancer, offering an opportunity to educate on the risks of the disease and the benefits of screening.

The ARASTEP trial is exploring the combination of darolutamide plus ADT vs ADT alone in patients with high-risk biochemical recurrence of prostate cancer.

The test utilizes chromosomal instability signatures to predict resistance to taxane-based chemotherapy in metastatic prostate cancer.

Olivares cautioned that HIFU is not suitable for all patients, particularly those with more aggressive disease, for whom complete gland removal may still be necessary.

The results demonstrated a favorable ratio between radiation doses absorbed in the tumor vs the doses delivered to key healthy organs.

“The takeaway is that on a population level, on a health care system perspective, it's more cost-effective and safer to do transperineal prostate biopsy,” says Mitchell M. Huang, MD.

The approach was associated with a 30% decrease in PSMA uptake by the salivary glands without compromising the treatment’s efficacy.

Alicia K. Morgans, MD, MPH, highlights quality of life data from the phase 3 ARANOTE trial.

The findings strongly support a proactive approach to identifying and referring patients with poor urinary function after RP.

The phase 1 study is set to begin later this year.

The approval is supported by data from the pivotal phase 3 ARANOTE trial.

The investigators found a clear, dose-response relationship between patient-reported incontinence severity and the subsequent use of incontinence interventions such as artificial sphincters or bulking agents.

"Overall, these findings add to the growing body of evidence that [shows that] apalutamide may offer a survival advantage in real-world setting in patients with metastatic castration-sensitive prostate cancer," says Mehmet A. Bilen, MD.

The IDeate-Prostate01 trial plans to enroll approximately 1440 patients whose tumors progressed following prior treatment with an ARPI.

ArteraAI is a multimodal artificial intelligence biomarker test that can predict therapy benefit and prognosticate long-term outcomes in prostate cancer.

“Our findings support that that we do not drop the label of cancer from grade group 1 nomenclature," says Jim C. Hu, MD, MPH.

A significant challenge lies in differentiating prostate cancer symptoms from common age-related issues.

Pfizer has chosen to no longer pursue an expanded indication for talazoparib plus enzalutamide in non-HRR gene mutated mCRPC in the US as a result of this decision.

Murilo De Almeida Luz, MD, discusses data on PSA and ALP changes in patients receiving enzalutamide plus radium-223 vs enzalutamide alone.

A primary concern was establishing trust in the connectivity to ensure no loss in visualization or connection.

One key approach is to increase the representation of women on editorial boards of journals and as reviewers.

"I'm excited to see how these models are going to continue to be developed and applied in clinical practice, because precision medicine is here, and I’m looking forward to it," says Madhur Nayan, MD, PhD.

Loeb stressed the importance of individualized decision-making based on life expectancy and overall health rather than age alone.